Combining the strengths of UMIST and

The Victoria University of Manchester

Research Ethics

Dr Mary TullySchool of Pharmacy and Pharmaceutical Sciences &

Chair of Salford & Trafford NHS Ethics Committee (2007-2009)

Presentation

• Remit of NHS ethics committees

• Imminent changes

• Ethics application process within NHS

• Information required for ethical consideration of research

Key Principles of Ethical Research

• Well-being of subject takes precedence over interests of science and society

• It is the duty of the physician to protect the life, health, privacy and dignity of the human subject

• Conform to generally accepted scientific principles by appropriately qualified persons

• Assessment of predictable risks and burdens in comparison with foreseeable benefits – the former should outweigh the latter

• Subjects must be volunteers and informed participants

NHS Research Ethics Committees Organisation

• NHS ethics committees were previously independent bodies

• Now controlled by a single body (NRES) with a single set of Standard Operating Procedures

• Operate under the Governance Arrangements for Research Ethics Committees (GAfREC)

• Use a single form for all ethics committees

• Approval from a single ethics committee is acceptable to all other committees

Currently - Studies Needing NHS REC Approval

• Those that involve:

– patients and users of the NHS

– relatives or carers of patients and users of the NHS

– access to data, organs or other bodily material of past and present NHS patients

– foetal material and IVF involving NHS patients

– the recently dead in NHS premises

– the use of, or potential access to, NHS premises or facilities

– NHS staff - recruited by virtue of professional role

GAFREC version 2 – out for consultation

• 2.3.2 Those that involve:

– past or present users of NHS & adult social services

– relatives or carers of past or present users of these services;

– collection of tissue/information from users of these services;

– use of previously collected tissue or information from which individual past or present users of these services could be identified

2.3.5 – Legislation requires REC review of research involving:

• (a) people who lack (or lose) the capacity to give informed consent to take part (or to keep taking part) in the research;

• (b) processing of confidential patient information without consent where this would otherwise breach confidentiality;

• (c) material consisting of or including human cells (unless anonymous & obtained with consent);

• (d) people who are cared for in the private and voluntary sector, e.g. in nursing homes or residential care homes;

• (e) exposure to ionising radiation;

• (f) medical devices that are not CE-marked (i.e. not compliant with European Directives) or CE-marked medical devices that have been modified or are being used for a new purpose;

• (g) investigational medicinal products;

• (h) practising midwives conducting a clinical trial; or

• (i) protected information from the Human Fertilisation and Embryology Authority register.

“No material ethical issues”

• Proportionate ethical review pilot in London from 1st September 2009

– Research using data or tissue that is anonymous TO THE RESEARCHER

– Research using existing tissue samples already taken with consent for research

– Research using “extra tissue” (e.g. further blood taken at time of routine sampling or tissue taken at “clinically directed” operation)

– Questionnaire research that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences

– Research interview / focus group that does NOT include highly sensitive areas or where accidental disclosure would NOT have serious consequences

– Research surveying the safety or efficacy of established non drug treatments, involving limited intervention and NO change to the patients’ treatment

http://www.nres.npsa.nhs.uk/applications/guidance/#appguide

Complete ethics applicationform

Phone to book in & get number

Submit completed form and supporting documentation

Application reviewed by main REC

Favourable Unfavourable

Sponsor ensures scientific review

Submit study to R&D office at each site

AppealTrust approval at each site

Modifications & reapply

From April 2009

Provisional

Modifications

www.myresearchproject.org.uk/

Membership of committees

• Salford & Trafford as an example

– Pharmacist

– Paediatric oncologist

– GP

– Nurse x 3

– Anaesthetist

– Medical statistician

– Clinical psychologist

– Community health care worker

– Retired physicist

– Engineer

– Professor in Cell Biology

– Builder

How to really annoy an ethics committee!

• Assume we are all experts in your area

• Assume that we are all stupid

• Assume that the research participant is an expert in your area

• Don’t answer the questions on the form

• Don’t bother proofreading

• Be really careless

Lay language

• “It is crucial that your answers to these questions are written in a way that will be understood by lay members of the Committee.

• Lay members may not have worked in the NHS or have any experience of clinical research.

• It is not acceptable to cut and paste from the protocol.

• You could be asked to rewrite your answers if you do not adhere to this guidance.”

• “The principal objective is to study the frequency of different allelic forms of immune response genes that may contribute towards the pathogenesis of various rheumatic and/or autoimmune diseases. Specific genetic polymorphisms may contribute to either the development of disease (susceptibility), the development of specific disease features (e.g. pattern of joint involvement and extra-articular manifestations) or alternatively may contribute to disease severity.”

What does committee look for?

• Scientific design & conduct of study

• Recruitment of research participants

• Consent

• Care & protection of research participants

• Protection of participants’ confidentiality

• Other considerations

• Will this research answer the question the researcher has posed?

• Does the research involved a placebo? How ethical is this? Have subjects being told?

• What are the criteria for prematurely withdrawing research participants?

• Etc …

Scientific design & conduct of study e.g.

• How will initial contact and recruitment be conducted?

• What are the inclusion and exclusion criteria for research participants, and are they justified?

• Etc …

Recruitment of research participants e.g.

Consent e.g.

• How will consent to be obtained?

• Is the information given appropriate, complete and understandable?

• What is the justification for including individuals who cannot consent?

• Etc …

Subject Information Sheets e.g.

• Question and answer format – standard NRES format

• Plain, concise English

• Should be true and not withhold information

• Risks and benefits outlined - of both arms in a controlled study

• Etc …

Care and protection of research participants e.g.

• Are there any plans to withhold or withdraw standard therapies?

• Will the research participants received any compensation/reward for their participation?

• Etc …

Protection of participants’ confidentiality e.g.

• Who will have access to the personal data of the research participants?

• To what extent will information about participants be anonymous?

• Will data be sent outside the EU?

• Etc …

Conclusions

• Changes are coming to the system in next 6 months

– New GAFREC

– Proportionate review system

• Take advice from as many people as you can

• Take advice from ethics committee members or coordinator

• Getting ethics approval may not be as awful as you think!